Related Experiment Video
Updated: Jul 16, 2026
23:33
The WATCHMAN Left Atrial Appendage Closure Device for Atrial Fibrillation
Published on: February 28, 2012
83.6K
Left atrial appendage occlusion for patients with valvular diseases without atrial fibrillation (the OPINION Study):
Fan Ju1, Xin Yuan1, Hansong Sun2
1Department of Cardiac Surgery, Chinese Academy of Medical Sciences & Peking Union Medical College Fuwai Hospital, Xicheng District, Beijing, China.
BMJ Open
|February 7, 2024
Summary
Surgical left atrial appendage occlusion (SLAAO) during valve surgery may prevent long-term stroke in patients without atrial fibrillation (AF). This trial investigates SLAAO
Area of Science:
- Cardiovascular Surgery
- Neurology
- Clinical Trials
Background:
- Atrial fibrillation (AF) is a major cause of perioperative stroke in aortic and mitral valve surgery.
- Previous studies on surgical left atrial appendage occlusion (SLAAO) are retrospective and may have confounding factors.
- Opportunistic SLAAO during cardiac surgery is being investigated for stroke prevention in specific patient groups.
Purpose of the Study:
- To test the hypothesis that opportunistic SLAAO can prevent long-term stroke after cardiac surgery.
- To evaluate the efficacy of SLAAO in patients undergoing mitral or aortic valve surgery without a history of AF and with a CHA2DS2-VASc score of 2 or higher.
- To assess the impact of SLAAO on stroke and cardiovascular mortality.
Main Methods:
- A single-blinded, multicentre, randomised controlled trial involving 2118 patients.
- Patients undergoing aortic or mitral surgery without AF will be randomized 1:1 to intervention (SLAAO) or control groups.
- The primary outcome is a composite of new ischemic stroke, transient ischemic attack, and cardiovascular mortality over 1 year.
Main Results:
- This section is to be filled once the trial results are available.
- The study is currently recruiting patients and has not yet produced results.
- Data collection and analysis will occur post-completion of patient follow-up.
Conclusions:
- This trial will provide crucial data on the effectiveness of SLAAO in preventing stroke in a high-risk surgical population.
- Findings will inform clinical practice regarding the prophylactic use of SLAAO during valve surgery.
- The study aims to reduce the incidence of stroke and improve long-term outcomes for cardiac surgery patients.
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